510(k) K090767

PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER by Interventional Spine, Inc. — Product Code MRW

K090767 is an FDA 510(k) premarket notification submitted by Interventional Spine, Inc. for the device "PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER". The FDA issued a decision of SESU on June 11, 2009. The device falls under product code MRW (System, Facet Screw Spinal Device), a Class U device. Interventional Spine, Inc. has at least 7 other 510(k) clearances on record.